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| Product NDC Code | 84328-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 252294 | ||||
| Application Number | M002 | ||||
| Labeler Name | SHANDONG ROSEMED BIOOHARM LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) Simethicone 180 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C yellow#6, gelatin, glycerin, purified water and white edible ink
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves bloating, pressure or fullness commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Anti-gas
Spl product data elements
Usually a list of ingredients in a drug product.SIMETHICONE Simethicone 180 mg WATER GLYCERIN FD&C YELLOW NO. 6 DIMETHICONE DIMETHICONE (oval)
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.1
SIMETHICONE: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information store at room temperature 59º - 86ºF (15º - 30ºC)
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.keep out of reach of children Keep out of reach of children.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Stop use and ask a doctorif condition persists Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API